One multiregional trial, no bridging studies: enforce ICH E17 in Japan and China
Japan and China have often required extra local studies before accepting a global trial. Committing to accept well-designed global trials would bring drugs to Asian patients years earlier.
ICH E17 (2017) describes how a multiregional clinical trial can support approval in all participating regions. In practice, sponsors still run bridging or local phase 1 studies for Japan and China, and China's requirement for local data has only partly relaxed. The proposal is a formal commitment by PMDA and NMPA, monitored through ICH, that MRCTs meeting E17 criteria (pre-specified regional enrolment, consistency assessment) remove the need for bridging studies, with a published list of exceptions.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Trials do not represent the people who get cancer · Older, Black, Hispanic, Asian, rural, poor and multimorbid patients are under-represented, so results may not apply to them.
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